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Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

NCT03816202 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-01-14

Study results available
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Summary

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

Sundt carotid shunt

The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Andrew Tummon · Integra LifeSciences

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2019-08-27
Completion
2019-08-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816202 on ClinicalTrials.gov